Youha

The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump powered by a rechargeable Li-ion battery. It consists of a Pump, Diaphragm, Cup, Valve, Silicone…

Registry build 21.09.26

The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump powered by a rechargeable Li-ion battery. It consists of a Pump, Diaphragm, Cup, Valve, Silicone breast shield (flange) and dust cap: The pump is the core component of the electric breast pump. It generates a cyclic negative pressure(vacuum) to simulate a baby’s sucking motion, drawing milk from the breast into the collection system. The pump is electrically driven and controlled via a motor and control unit, typically offering adjustable suction levels and mode. The diaphragm separates the milk collection system from the pump mechanism, preventing breast milk from entering the pump motor and tubing. The cup is the container that collects and stores the expressed breast milk. The valve controls the one-way flow of breast milk. It opens and closes in sync with the suction cycles to allow milk to flow into the cup while preventing backflow. The silicone breast shield, also known as the flange, is the part that comes into direct contact with the breast. It creates a seal around the nipple and areola to enable effective suction. The dust cap covers the opening of the breast shield or milk collection port when the electric breast pump is not in use. It prevents dust, dirt, and other contaminants from entering the breast pump

40manufacturers in China registered for this device type
14catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (28), Zhejiang (5), Hong Kong (2). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HGX
Manufacturer City Province Registered as Device types
Essentia Industries Ltd. Dong Guan Guangdong Contract manufacturer 31
Alleva Medical (D.G.) Ltd Dongguan Guangdong Contract manufacturer 13
Joytech Healthcare Co., Ltd. Hangzhou Zhejiang Contract manufacturer 9
JDI Electronics Factory Dongguan Guangdong Contract manufacturer 7
Guangdong Xinbao Electrical Appliances Holdings Co., Ltd. Foshan Guangdong Contract manufacturer 6
Jiangsu Xinbei Electrical Appliances Co., Ltd. Wuxi Jiangsu Contract manufacturer 6
Shenzhen Jingxintai Houseware Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
Huizhou LVB Maternal AND Infant Supplies Co., Ltd. Huizhou Guangdong Contract manufacturer 3
Huizhou Sunwinon Electronics Co., Ltd. Huizhou Guangdong Contract manufacturer 3
Mastars Industries Co., Ltd. Guangdong Guangdong Contract manufacturer 3
Rrdonnelley Dongguan Guangdong Contract manufacturer 3
SFY Intelligent Technology (Suzhou) Co., Ltd. Kunshan Jiangsu Contract manufacturer 3

Showing 12 of 40. All 40 manufacturers in China registered for Pump, Breast, Powered

Record

Regulatory record for Youha
Listed by Ningbo Youhe Mother And Baby Products Co., Ltd.
FDA product code HGX
Device type Pump, Breast, Powered
Device class Class 2
Regulation 21 CFR 884.5160
510(k) K163136
Record published 2026-01-07

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date
Packaging Pack of 12, pack of 20, pack of 10, pack of 18

Catalogue Numbers

Catalogue numbers for Youha
Catalogue number Size Status
YH-8006IV In distribution
FZ-P8 In distribution
YH-P8X In distribution
YH-8004 In distribution
YH-8015 In distribution
THe INs Gen 2 In distribution
YH-8016 In distribution
YH-P8 In distribution
YH-8012 In distribution
The INs In distribution
The INs NEXT In distribution
YH-8019 In distribution
THE ONE In distribution
YH-8011 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Spectra Uzinmedicare Co., Ltd. 144
Freemie Dao Health 93
Ameda, Inc. Ameda, Inc. 72
Motif Medical Cimilre Co., Ltd. 47
Momcozy Shenzhen Root Innovation Technology Co., Ltd. 44
Symmetrical Health, LLC Cimilre Co., Ltd. 28
Electric Breast Pump Ningbo Huiyoo Baby Products Co., Ltd. 28
Ameda® Cimilre Co., Ltd. 22
LVB Huizhou LVB Maternal & Infant Supplies Co., Ltd. 17
Vive Vive Health LLC 17
ViveCare Vive Health LLC 16
Stella Baby USA Cimilre Co., Ltd. 15

Showing 12 of 307. All products under Pump, Breast, Powered

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer